Duns Number:529854247
Device Description: Phototherapy Systems
Catalog Number
-
Brand Name
Apolomed
Version/Model Number
HS-770
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 05, 2025
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K190938
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
1cfc0ff3-0d81-4d5f-b19d-6d50606b9740
Public Version Date
January 14, 2020
Public Version Number
1
DI Record Publish Date
January 06, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 23 |